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Key Strategies & Considerations in Remote Regulatory Inspections

Preparing for Remote Regulatory Inspections: Key Strategies & Considerations 

Blogs, Regulatory /

The COVID-19 pandemic catalyzed a shift in how regulatory authorities conduct inspections, accelerating the adoption of remote regulatory inspections (RRIs) as a pragmatic alternative to traditional onsite audits. While initially a contingency approach, RRIs have now evolved into a sustainable model widely accepted by health authorities such as the U.S. FDA, EMA, MHRA, and Health […]

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One Health veterinary regulations ensuring animal and public health.

One Health Framework in Veterinary Medicine & Regulations 

Blogs, Regulatory /

In recent years, regulatory conversations within the life sciences sector have increasingly emphasized the importance of a unified approach to human, animal, and environmental health what is now commonly referred to as the One Health framework. Far from being a conceptual model, One Health has become a practical foundation influencing regulatory policies worldwide, particularly in

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AI in legal and compliance pharmaceutical industry

Expanding Legal and Compliance Responsibilities in the Era of AI

Blogs, Regulatory /

As Artificial Intelligence (AI) rapidly redefines the pharmaceutical processes, it is not just science and operations that are evolving, so are the legal and compliance frameworks that govern them. Once confined to the realm of data science, AI has now become a boardroom priority, demanding urgent attention from legal, regulatory, and compliance professionals. From algorithm-driven

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Regulatory Landscape for Biosimilars in Southeast Asia

Blogs, Regulatory /

The biopharmaceutical industry is witnessing an inflection point with the growing prominence of biosimilars, therapeutic products that are highly similar to, and have no clinically meaningful differences from, existing reference biologics. In Southeast Asia, a region marked by diverse healthcare systems and economic disparities, biosimilars present an unprecedented opportunity to improve access to life-saving biologics.

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REMS Audits and Inspections

REMS Audits and Inspections: What You Need to Know

Blogs, Pharmacovigilance /

Risk Evaluation and Mitigation Strategies (REMS) are special safety programs required by the U.S. Food and Drug Administration (FDA) for certain drugs and biologics with serious safety concerns. These programs are designed to ensure that a product’s benefits outweigh its risks. REMS may include strategies such as restricted distribution, prescriber certification, patient education, training, and

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Key Developments & Implications of the European Health Data Space

Blogs, Pharmacovigilance, Regulatory /

In an age where data is often called the new oil, the healthcare sector is sitting on a goldmine of untapped potential. Every day, vast amounts of health data are generated across the European Union, offering incredible opportunities to transform the way healthcare is delivered, researched, and managed. Enter the European Health Data Space (EHDS)—a

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Challenges Risk Assessment in Veterinary

Navigating the Complexities of Risk Assessment in Veterinary Pharmaceuticals 

Blogs, Pharmacovigilance, Regulatory /

The development of veterinary medicines faces numerous challenges that are unique compared to human pharmaceutical development. Although the pharmaceutical industry in both sectors is built on shared principles of safety and efficacy, the veterinary pharmaceutical industry is confronted with a significantly more complex risk environment. The distinctive risk assessment challenges of veterinary pharmaceuticals and how

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All About Software as a Medical Device (SaMD)

Understanding Software as a Medical Device (SaMD)

Blogs, Medical Device /

The International Medical Device Regulators Forum (IMDRF) defined Software as a Medical Device (SaMD) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. The FDA also aligns with this, noting SaMD runs on general-purpose computing platforms, such as smartphones or

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Roadblocks in Global Pharmacovigilance Harmonization

Overcoming Roadblocks in Global Pharmacovigilance Harmonization

Blogs, Pharmacovigilance /

Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem”. Global Pharmacovigilance Harmonization, on the other hand, refers to the process of aligning regulations, practices, and standards across countries and regions in order to

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US FDA Radiological Health Regulations

Navigating US Regulations in Radiological Health 

Blogs, Regulatory /

Radiological health involves the safe use of radiation in medical diagnosis, treatment, and industrial applications. Its goal is to minimize unnecessary radiation exposure for patients, healthcare workers, and the public. Regulation is critical for managing the risks of ionizing radiation (such as cancer risks from excessive exposure).  As we navigate through 2025, staying informed about

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